QA Manager (External Quality/Third Party Compliance)
Hyper Recruitment Solutions are currently looking for a QA Manager (External Quality/Third Party Compliance) to join a leading Global Pharmaceutical company based in the Cambridgeshire area. As the QA Manager (External Quality/Third Party Compliance) you will be responsible for taking the lead on ensuring GMDP compliance of a Global Audit program across an established and growing product portfolio.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Manager (External Quality/Third Party Compliance). will be varied however the key duties and responsibilities are as follows:
1. You will conduct audits of manufacturers, suppliers and storage areas of finished product (medicinal/non medicinal), API's, packaging components, raw materials and distributors. This will include completion of the full audit life cycle including writing a audit report circulating internally and closing in a timely manner, major issues will be raised to the Audit manager.
2. The QA Manager (External Quality/Third Party Compliance) will take the lead in strategic projects including new product introductions, supplier approvals, as well as managing the risk register for third parties to contribute to compliant planning of annual audit schedules.
3. You will generate and update relevant SOP's/Quality Documentation ( i.e Technical Quality Agreements) as well as assisting with the generation and interpretation of Key Quality Metrics to ensure continued compliance, you will be a SME for compliance related issues and maintain current expertise of key legislation.
4. Perform internal Quality Audits to maintain compliance with Global IAC's, this will ensure that business activities meet the requirements for Quality, Health and Safety, Ethics, and general duty of care. You will understand the nature of the organisation and drive improvement as well as supporting customers with enquires.
To be successful in your application to this exciting opportunity as the QA Manager (External Quality/Third Party Compliance). we are looking to identify the following on your profile and past history:
1. Proven industry experience in ensuring the compliance of a Pharmaceutical Business to GMDP Standards, including taking the lead on Quality Projects to ensure compliance of a pharmaceutical supply chain.
2. A working knowledge and practical experience with assessing the compliance of Third Parties, as well as conducting Audits as a lead auditor (IRCA qualified or equivalent).
3. You should have experience of a broad range of pharmaceuticals including various dosage forms and risk levels, with an appreciation of the differences between regulatory guidelines (EU, WHO, ISO, ICH, PIC/S, FDA).
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
This job was originally posted as www.jobsite.co.uk/job/959429413